Head and Neck NeoplasmsPhase 1/2NCT00982436
Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer
A Phase 1/2 study testing Docetaxel/cisplatin, Radiotherapy and Carboplatin in people with Head and Neck Neoplasms, run by University of Vermont at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel, followed by carboplatin given at the same time as radiotherapy in the treatment of locally advanced head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Docetaxel/cisplatin, Radiotherapy and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- Measurable or evaluable disease
- No distant metastases
- Tumor should be surgically unresectable for cure or resection is considered inadvisable
- Age > 18 years
- ECOG performance status 0, 1 or 2
Show all 19Show fewer
- Life expectancy > 2 months
- Patients must have adequate organ and marrow function as defined below:
- Leukocytes > 3,000/mm3
- Absolute neutrophil count > 1,500/mm3
- Platelets > 100,000/mm3
- Hemoglobin > 10.0g/dL
- Total Bilirubin <= institutional upper limit of normal
- Aspartate aminotransferase < 2.5 X institutional upper limit of normal
- Alanine aminotransferase < 2.5 X institutional upper limit of normal
- Alkaline phosphatase < 2.5 X institutional upper limit of normal
- Creatinine <= institutional upper limit of normal OR creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine > institutional upper limit of normal
- Signed informed consent
- Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment
Who cannot join
- Previous chemotherapy for this malignancy
- Previous radiotherapy to head and neck region
- Other malignancy within last 5 years except for non-melanoma skin cancer
- Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
- Peripheral neuropathy > Grade 2
- Hypercalcemia
- Patient is pregnant or lactating
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Mountainview Medical Center
Berlin Corners, Vermont, 05602
John Valentine, MD, 802-225-5400, john.valentine@cvmc.org
John Valentine, MD
- Recruiting
Fletcher Allen Health Care
Burlington, Vermont, 05401
Steven Grunberg, MD, 802-847-8400, Steven.Grunberg@vtmednet.org
Madhuri V Vithala, MD, 802-847-8400, Madhuri.Vithala@vtmednet.org
- Recruiting
Vermont Center for Cancer Medicine
Colchester, Vermont, 05446
Christian Thomas, MD, 802-655-3400, Christian.Thomas@vtmednet.org
Paul Unger, MD
About this study
Official title: A Pilot Study to Evaluate Response to Neoadjuvant Chemotherapy With Cisplatin and Docetaxel Followed by Chemoradiation Therapy With Carboplatin in Stage IV Non-metastatic Head and Neck Cancer
The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel, followed by carboplatin given at the same time as radiotherapy in the treatment of locally advanced head and neck cancer.
Read the detailed description
Chemoradiotherapy has become the standard of care for patients with unresectable head and neck cancer, but there can be substantial added toxicity with chemoradiotherapy compared to radiation therapy alone. Neoadjuvant therapy with cisplatin / 5-fluorouracil has demonstrated activity in this disease, and taxanes appear to improve response further. Docetaxel / cisplatin / 5-fluorouracil has been shown to be a highly active regimen. However, with the potential added toxicities of neoadjuvant chemotherapy, it is important to minimize toxicity while maintaining efficacy. Chemotherapeutic agents that are DNA cycle-specific like 5-fluorouracil are more stomatotoxic than those that are cell phase non-specific. Of note, several studies have suggested that docetaxel and cisplatin is a highly active combination when used for advanced disease or as neoadjuvant therapy .
This study will therefore test the efficacy of neoadjuvant chemotherapy with cisplatin and docetaxel without 5-fluorouracil followed by chemoradiotherapy with carboplatin to determine whether promising response rates with modest toxicity can be achieved. Carboplatin will be used as the radiosensitizing agent during chemoradiotherapy to reduce nephrotoxicity and neurotoxicity as compared to further treatment with cisplatin.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Docetaxel/cisplatin, Radiotherapy, Carboplatin
- Keywords
- Combined Modality Therapy, Neoadjuvant Therapy, Head and neck neoplasms
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel/cisplatinDrug
Also called Taxotere, Platinol
Docetaxel 75 mg/m2 intravenous every 3 weeks for 3 cycles Cisplatin 75 mg/m2 intravenous every 3 weeks for 3 cycles
RadiotherapyRadiation
Also called Radiation therapy
70 Gy in 35 fractions to gross tumor and lymph node metastases
CarboplatinDrug
Also called Paraplatin
Carboplatin AUC 1.5 intravenous weekly during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant/Concomitant Chemoradiation | Experimental | Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin Receives: Drug: Docetaxel/cisplatin; Radiation: Radiotherapy; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Measured: 6 months after initiation of therapy
Secondary outcomes (5)
Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer
Measured: 3 months after initiation of therapy
Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer
Measured: 6 months after initiation of therapy
Toxicity of neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Measured: Every 3 weeks for 6 months (during therapy)
Progression free survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Measured: Every 6 months
Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Grunberg, University of Vermont
- Investigators
- Steven M Grunberg, MD, Principal investigator, University of Vermont/Feltcher Allen Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982436
- Sponsor's protocol ID
- VCC 0905
- Status last verified
- Mar 2012
- First submitted
- 22 Sep 2009
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Response to Neoadjuvant Chemotherapy With Cisplatin and Docetaxel Followed by Chemoradiation Therapy With Carboplatin in Stage IV Non-metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00982436
- Acronym / sponsor ID
- VCC 0905
- Conditions
- Head and Neck Neoplasms
- Keywords
- Combined Modality Therapy, Neoadjuvant Therapy, Head and neck neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel, followed by carboplatin given at the same time as radiotherapy in the treatment of locally advanced head and neck cancer.
Detailed description
Chemoradiotherapy has become the standard of care for patients with unresectable head and neck cancer, but there can be substantial added toxicity with chemoradiotherapy compared to radiation therapy alone. Neoadjuvant therapy with cisplatin / 5-fluorouracil has demonstrated activity in this disease, and taxanes appear to improve response further. Docetaxel / cisplatin / 5-fluorouracil has been shown to be a highly active regimen. However, with the potential added toxicities of neoadjuvant chemotherapy, it is important to minimize toxicity while maintaining efficacy. Chemotherapeutic agents that are DNA cycle-specific like 5-fluorouracil are more stomatotoxic than those that are cell phase non-specific. Of note, several studies have suggested that docetaxel and cisplatin is a highly active combination when used for advanced disease or as neoadjuvant therapy .
This study will therefore test the efficacy of neoadjuvant chemotherapy with cisplatin and docetaxel without 5-fluorouracil followed by chemoradiotherapy with carboplatin to determine whether promising response rates with modest toxicity can be achieved. Carboplatin will be used as the radiosensitizing agent during chemoradiotherapy to reduce nephrotoxicity and neurotoxicity as compared to further treatment with cisplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant/Concomitant Chemoradiation | Experimental | Drug: Docetaxel/cisplatin, Radiation: Radiotherapy, Drug: CarboplatinThree cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- Measurable or evaluable disease
- No distant metastases
- Tumor should be surgically unresectable for cure or resection is considered inadvisable
- Age > 18 years
Key exclusion criteria (7 listed)
- Previous chemotherapy for this malignancy
- Previous radiotherapy to head and neck region
- Other malignancy within last 5 years except for non-melanoma skin cancer
- Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
- Peripheral neuropathy > Grade 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel/cisplatinAlso: Taxotere, PlatinolDocetaxel 75 mg/m2 intravenous every 3 weeks for 3 cycles Cisplatin 75 mg/m2 intravenous every 3 weeks for 3 cycles | Drug | Neoadjuvant/Concomitant Chemoradiation |
| RadiotherapyAlso: Radiation therapy70 Gy in 35 fractions to gross tumor and lymph node metastases | Radiation | Neoadjuvant/Concomitant Chemoradiation |
| CarboplatinAlso: ParaplatinCarboplatin AUC 1.5 intravenous weekly during radiotherapy | Drug | Neoadjuvant/Concomitant Chemoradiation |
Primary outcome
Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Time frame: 6 months after initiation of therapy
5 secondary outcomes
Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer
Time frame: 3 months after initiation of therapy
Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer
Time frame: 6 months after initiation of therapy
Toxicity of neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Time frame: Every 3 weeks for 6 months (during therapy)
Progression free survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Time frame: Every 6 months
Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
Time frame: Every 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M Grunberg, MD principal investigator
University of Vermont/Feltcher Allen Health Care
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel/cisplatin, Radiotherapy and Carboplatin in people with Head and Neck Neoplasms, run by University of Vermont at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven M Grunberg, MD (802-847-8400, Steven.Grunberg@vtmednet.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer (time frame: 6 months after initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.